FDA.reportPublic FDA data

NDC 20482-006-01 - SUBSYS

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
20482-006
Requested NDC
20482-006-01
Package NDCs from labels
20482-006-30, 20482-006-10, 20482-006-01
Manufacturer
Insys Therapeutics, Inc.
Effective date
2021-05-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SUBSYS - Insys Therapeutics, Inc.Insys Therapeutics, Inc.2021-05-04HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-11Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
20482-006-102023-01-30C16284748780-1f386c649-9b75-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SUBSYS safely and effectively. See full prescribing information for SUBSYS. SUBSYS®(fentanyl sublingual spray), CII Initial U.S. Approval: 1968
20482-006-302023-01-30C16284748780-1f386c649-9b75-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use SUBSYS safely and effectively. See full prescribing information for SUBSYS. SUBSYS®(fentanyl sublingual spray), CII Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
20482-006-10SUBSYS1 in 1 BLISTER PACKSPRAY121
20482-006-10SUBSYS10 in 1 CARTONSPRAY1021
20482-006-30SUBSYS30 in 1 CARTONSPRAY3021
20482-006-30SUBSYS1 in 1 BLISTER PACKSPRAY121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
20482-006SUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]21Legacy NDC, 4 package rows20210506_18a413e9-11e0-4a8f-86c0-d33b37b7b771.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
20482-006-01EA - Each20482-006e4bfcc54-80fb-44ea-8755-628d50d1842212013-02-11
20482-006-30EA - Each20482-0065eb58cb8-ae5b-4020-b7c1-719390f3983212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYLACTIVE INGREDIENTUF599785JZSUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
FENTANYLACTIVE MOIETYUF599785JZSUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
alcoholINACTIVE INGREDIENT3K9958V90MSUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
levomentholINACTIVE INGREDIENTBZ1R15MTK7SUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
waterINACTIVE INGREDIENT059QF0KO0RSUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12
xylitolINACTIVE INGREDIENTVCQ006KQ1ESUBSYS (FENTANYL) SPRAY [INSYS THERAPEUTICS, INC.]12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FENTANYL TRANSDERMALFENTANYL TRANSDERMALSpecGx LLCe15a7e9b-8025-49dd-9a6d-bafcccf1959f2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UF599785JZ
FENTANYLFENTANYLAveva Drug Delivery Systems Inc.73897c38-e4ec-40bc-9f41-3359ee23a5a82026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UF599785JZ
FENTANYLFENTANYLINGENUS PHARMACEUTICALS, LLCbf02ffd0-cc5d-446b-b648-378f6885052f2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UF599785JZ
Fentanyl systemFENTANYLALVOGEN242759ef-cb6d-4e3e-9f8d-5e31efa1f2892026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UF599785JZ
FENTANYLFENTANYLMylan Pharmaceuticals Inc.2a2238e9-4b5d-c56d-8663-dd354ff9ae0c2025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UF599785JZ
c185344a-1761-53e2-e053-2995a90a003818a413e9-11e0-4a8f-86c0-d33b37b7b7712021-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: c185344a-1761-53e2-e053-2995a90a0038
spl set id: 18a413e9-11e0-4a8f-86c0-d33b37b7b771

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.